The aim of this translational research project is to conduct a first in human (clinical phase I) study and test BAP5191, a new formulation intended to be a cure for cutaneous leishmaniasis – a neglected stigmatizing and debilitating tropical disease with an estimated 600 000 to 1 million of new cases occurrence worldwide annually.
The industry partner, Bacoba AG, will be the Sponsor of the study and supply documentation, test substance, the IND enabling studies and oversight of the project. The Clinical Operations Unit at the Swiss Tropical and Public Health Institute (Swiss TPH) will design and manage the study as a main research partner. The study site will be conducted at the Basel University Hospital at the Clinical Trials Unit (CTU).
The long-term objective is after a successful Phase I to proceed to clinical trials phase II and III, and license the product, with the ultimate goal of meeting an important unmet clinical need, by suppling millions neglected patients with safe, affordable and easy to use novel cure for cutaneous leishmaniasis. In addition, this project will be pivotal in establishing the technological platform from which the active pharmaceutical ingredient in the BAP5191 formulation will be translated into a medicinal product and implemented for human use.